Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Flurbiprofen
Reckitt Benckiser Ireland Ltd
R02AX; R02AX01
Flurbiprofen
8.75 milligram(s)
Lozenge
Product not subject to medical prescription
Other throat preparations; flurbiprofen
Authorised
2014-07-04
STREPSILS INTENSIVE ORANGE SUGAR FREE 8.75MG LOZENGES FLURBIPROFEN PATIENT INFORMATION LEAFLET Please read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better, or if you feel worse, after 3 days. WHAT IS IN THIS LEAFLET:- 1. What Strepsils Intensive Lozenges are and what they are used for 2. What you need to know before you use Strepsils Intensive Lozenges 3. How to use Strepsils Intensive Lozenges 4. Possible side effects 5. How to store Strepsils Intensive Lozenges 6. Contents of the pack and other information 1. WHAT STREPSILS INTENSIVE LOZENGES ARE AND WHAT THEY ARE USED FOR? The ingredient which makes this medicine work is called flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which help reduce inflammation (swelling) and pain. Strepsils Intensive Lozenges are for use in adults and children over 12 years of age to help relieve the symptoms of sore throats, such as soreness, pain and swelling. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STREPSILS INTENSIVE LOZENGES DO NOT TAKE THESE LOZENGES IF YOU: • Have or have ever had a STOMACH ULCER • Are ALLERGIC to flurbiprofen, aspirin or other NSAIDs or any of the other ingredients (see Section 6) • Have previously experienced GASTROINTESTINAL BLEEDING OR PERFORATION whilst taking NSAIDS • Have ever had BLOOD CLOTTING PROBLEMS OR BLEEDING PROBLEMS after taking NSAIDs • Have ever had WHEEZING, A RUNNY NOSE OR AN ITCHY RASH (hives) after taking aspirin, flurbiprofen or medicines containing NSAIDs • Are Baca dokumen lengkap
Health Products Regulatory Authority 08 February 2022 CRN00CNZC Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Intensive Orange Sugar Free 8.75mg Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One lozenge contains 8.75 mg of flurbiprofen. Excipients with known effects: This product contains Maltitol Liquid 0.51 g/lozenge. Total maximum daily dose (MDD) is 2.55 g. Isomalt 2.039 g/lozenge. Total maximum daily dose (MDD) is 10.195 g. Orange flavour containing allergens (citral, citronellol, d-limonene, geraniol and linalool) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge A round pale lozenge with a characteristic orange taste with an icon intagilated on both sides 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of sore throats. Strepsils Intensive Lozenge is indicated in adults and adolescents over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Treatment should be administered for the shortest duration necessary to control symptoms. It is recommended that this product should be used for a maximum of three days. ADULTS: One lozenge sucked/dissolved slowly in the mouth every 3 – 6 hours as required. Maximum 5 lozenges in any 24 hour period PAEDIATRIC POPULATION ADOLESCENTS OVER THE AGE OF 12 YEARS: As above for adults CHILDREN: Not indicated for children under 12 years (see section 4.3). ELDERLY: No dose modification is required. The elderly are at increased risk of the serious consequences of adverse reactions to NSAIDs (see section 4.4). HEPATIC IMPAIRMENT: In patients with mild to moderate hepatic impairment, no dose reduction is required. In patients with severe hepatic insufficiency flurbiprofen is contraindicated (see section 4.3). RENAL IMPAIRMENT: In patients with mild to moderate renal impairment, no dose reduction is required. In patients with severe renal insufficiency flurbiprofen is contraindicated (see section 4.3). METHOD OF ADMINISTRATION For oromucosal administration. To b Baca dokumen lengkap